Dispensing device

ABSTRACT

The invention relates to a device for the time-controlled dispensing of pharmaceutical compositions to a patient. The device is intended to allow multiple doses of pharmaceutical compositions to be delivered to a patient over a predetermined or programmable dosing schedule.

FIELD OF THE INVENTION

The present invention relates to devices used for dispensingpharmaceutical compositions to patients in a time-controlled manner.

BACKGROUND

Dispensing pharmaceutical compositions to patients is often complicatedby the need to limit the delivery to specific dosing regimens overspecific time periods. In the case of many pharmaceuticals, deliverytimes must be controlled to provide adequate and effective dosing overtime, while at the same time preventing inadequate dosing as well asoverdosing.

The problem is particularly acute with drugs that demand patientcompliance to optimize safety, while maximizing efficacy. Drugs thatfall into this class may have strict administration schedules andstringent dosing amounts as exemplified by such classes of molecules toinclude, but not limited to analgesics, cardiovascular agents, metabolicdisorder treatments, and drugs used to treat certain cancers. Such drugsmay be subject to overdosing as patients often seek medication prior tothe recommended or allowable prescribed dose and schedule, leading tothe possibility of adverse events, abuse or fatality.

In supervised healthcare settings, i.e., hospitals, nursing homes,hospices, clinics, and the like, the problem is addressed by enablinghealthcare practitioners to dispense fixed amounts of medication forpatients at prescribed times in a controlled fashion. In addition,dosing requires the presence of a practitioner to determine, monitor,and sometimes adjust the dosing regimen of the required drug or drugsdelivered to the patient in order to optimize efficacy and safety. Suchnecessary oversight places a large burden on the healthcare provider, asit requires personnel and detailed record-keeping for each patient.Likewise, in less controlled settings, supervision is still required toensure adequate treatment and to prevent either under or overdosingand/or abuse. A relevant example includes the home healthcare setting,where visiting nurses are often required to be present for the deliveryof individual drug doses to patients.

Therefore, a need exists for a user-friendly, simple drug-dispensingdevice that may contain several doses of a drug, provide individualdoses available to a patient at prescribed time intervals, and whichmoderates some degree of protection to the patient, both by deterringpotential over dosage and by making diversion by a family member orother visitor obvious.

SUMMARY AND OBJECTS OF THE INVENTION

One object of the present invention is to provide a simple device forstoring and dispensing prescription drugs.

A further object of the present invention is to provide a simple devicefor storing and dispensing drugs which are administered to a patient viaintranasal means.

A further object of the present invention is to provide a simple drugdispensing device that would allow a patient to receive drug doses atprescribed time intervals.

Another object of the present invention is to provide a drug dispensingdevice that is suitable for use in supervised, semi-supervised, andunsupervised healthcare settings.

Another object of the present invention is to provide a drug dispensingdevice having indicia thereon to indicate tampering or other attempts togain unauthorized access to the drugs contained therein.

Still another object of the present invention is to provide a drugdispensing device that can be programmed by a healthcare practitioner todispense drugs to a patient at prescribed intervals.

Still another object of the present invention is to provide a drugdispensing device that can be programmed by a healthcare practitioner toprevent dispensing drugs to a patient at less than prescribed timeintervals.

Yet another object of the present invention is to provide a drugdispensing device that would allow patients to self-administer drugsover a prescribed time period.

It is another object of the present invention is to provide a drugdispensing device that would allow patients to self-administer suchdrugs as analgesics, cardiovascular drugs, drugs used to treat metabolicdisorders, and drugs used to treat certain cancers when desired, but noearlier than at prescribed intervals.

It is another object of the present invention to provide a drugdispensing device that can dispense a prescribed drug regimen to apatient at prescribed time intervals.

The above and other objects may be achieved by providing a device forthe controlled release of drug delivery units which comprises a magazinefor containing a plurality of drug delivery units, a housing containingthe magazine having an aperture allowing drug delivery units to beremoved through the housing, a link by which the magazine may be movedrelative to the housing, and a timing mechanism in communication withthe link, for causing the magazine to be moved relative to the housing,thereby periodically allowing removal of individual drug delivery unitsthrough the aperture at pre-selected intervals. The device may beconfigured to allow dispensing of a specified number of drug deliveryunits over an extended time period, for example 12 or 24 hours or more,or it may be configured to allow dispensing of individual drug deliveryunits as desired by the patient, provided that the minimum intervalbetween each delivery is of a pre-specified length. The various timingand delivery issues may be controlled by a healthcare provider duringloading of the device or at some time thereafter.

The above objects and summary of the invention will be more fully setforth in the Figures and detailed description of the invention below.

DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic depiction of the device of the present invention.

FIGS. 2 a and 2 b are schematic depictions of intranasal drug deliveryunits delivered by one embodiment of the present invention.

FIGS. 3 a and 3 b are schematic top and side views of the base of oneembodiment of the present invention.

FIGS. 4 a and 4 b are schematic top and side views of the housing of oneembodiment of the present invention.

FIGS. 5 a-5 d are schematic top and side views of the magazine of twoembodiments of the present invention.

FIGS. 6 a and 6 b are schematic top and side views of the link of oneembodiment of the present invention.

FIG. 7 is a schematic depiction of the timing mechanism of oneembodiment of the present invention.

DETAILED DESCRIPTION

The invention relates broadly to a device for the controlled dispensingof drug delivery units. As used herein, the term “drug delivery unit” isintended to refer to a unit dose of a pharmaceutical composition or anapplicator for providing a unit dose of a pharmaceutical composition.Thus, while the term “drug delivery unit” may refer to a pill, tablet,capsule, caplet, etc., (i.e., a unit dose of a pharmaceuticalcomposition) which is ingested by a patient, the term is also intendedto refer to a device for delivering a unit dose of a pharmaceuticalcomposition to a patient. Examples herein include, but are not limitedto, intranasal applicators, such as applicators designed to deliver asingle unit or bidose or multiunit dose of a pharmaceutical compositionto a patient. Thus, as will become apparent, the present device may beused to dispense compositions which are ingestible as well as devicesfor delivering compositions which are administered by means other thaningestion. In one preferred embodiment, the invention is configured todispense intranasal applicators (such as those manufactured by Ing.Erich Pfeiffer GmbH, Radofzell, Germany; Pfeiffer of America, Princeton,N.J.), each loaded with a unit dose of intranasal ketamine, intranasalmorphine, or mixtures thereof, either with or without otherconstituents. Likewise, the invention may be configured to dispense morethan one drug delivery unit at any given time, or it may be configuredto dispense a drug delivery unit in the form of, for example, a capsuleat one or more time intervals and a drug delivery unit in the for of,for example, an intranasal applicator at one or more different timeintervals.

While the device is intended to be used to dispense any of a widevariety of drug delivery units, it is particularly adapted fordispensing controlled, scheduled drugs in a manner that prevents orprovides indicia of overdosing. As noted above, the device iswell-suited for the delivery of intranasal applicators, each loaded witha unit dose of intranasal ketamine, intranasal morphine, or mixturesthereof, either with or without other constituents; however, other drugdelivery units are contemplated as well. These include, but are notlimited to, the following drugs listed on DEA Schedules II, III, IV andV:

SCHEDULE II DEA Substance Number 1-Phenylcyclohexylamine 74601-Piperidinocyclohexanecarbonitrile 8603 Alfentanil 9737 Alphaprodine9010 Amobarbital 2125 Amphetamine 1100 Anileridine 9020 Benzoylecgonine9180 Bezitramide 9800 Carfentanil 9743 Coca Leaves 9040 Cocaine 9041Codeine 9050 Dextropropoxyphene, bulk (non-dosage forms) 9273Dihydrocodeine 9120 Diphenoxylate 9170 Diprenorphine 9058 Ecgonine 9180Ethylmorphine 9190 Etorphine HCl 9059 Fentanyl 9801 Glutethimide 2550Hydrocodone 9193 Hydromorphone 9150 Isomethadone 9226Levo-alphacetylmethadol 9648 Levomethorphan 9210 Levorphanol 9220Meperidine 9230 Meperidine intermediate-A 9232 Meperidine intermediate-B9233 Meperidine intermediate-C 9234 Metazocine 9240 Methadone 9250Methadone intermediate 9254 Methamphetamine 1105 Methylphenidate 1724Metopon 9260 Moramide-intermediate 9802 Morphine 9300 Nabilone 7379Opium extracts 9610 Opium fluid extract 9620 Opium poppy 9650 Opiumtincture 9630 Opium, granulated 9640 Opium, powdered 9639 Opium, raw9600 Oxycodone 9143 Oxymorphone 9652 Pentobarbital 2270 Phenazocine 9715Phencyclidine 7471 Phenmetrazine 1631 Phenylacetone 8501 Piminodine 9730Poppy Straw 9650 Poppy Straw Concentrate 9670 Racemethorphan 9732Racemorphan 9733 Remifentanil 9739 Secobarbital 2315 Sufentanil 9740Thebaine 9333

SCHEDULE III DEA Substance Number Amobarbital & noncontrolled activeingred. 2126 Amobarbital suppository dosage form 2126 Anabolic steroids4000 Aprobarbital 2100 Barbituric acid derivative 2100 Benzphetamine1228 Boldenone 4000 Buprenorphine 9064 Butabarbital 2100 Butalbital 2100Chlorhexadol 2510 Chlorotestosterone (same as clostebol) 4000Chlorphentermine 1645 Clortermine 1647 Clostebol 4000 Codeine &isoquinoline alkaloid 90 mg/du 9803 Codeine combination product 90 mg/du9804 Dehydrochlormethyltestosterone 4000 Dihydrocodeine combinationproduct 90 mg/du 9807 Dihydrotestosterone (same as stanolone) 4000Dronabinol in sesame oil in soft gelatin capsule 7369 Drostanolone 4000Ethylestrenol 4000 Ethylmorphine combination product 15 mg/du 9808Fluoxymesterone 4000 Hydrocodone & isoquinoline alkaloid 15 mg/du 9805Hydrocodone combination product 15 mg/du 9806 Ketamine 7285 Lysergicacid 7300 Lysergic acid amide 7310 Mesterolone 4000 Methandienone (seeMethandrostenolone) 4000 Methandranone 4000 Methandriol 4000Methandrostenolone 4000 Methenolone 4000 Methyltestosterone 4000Methyprylon 2575 Mibolerone 4000 Morphine combination product/50 mg/100ml or gm 9810 Nalorphine 9400 Nandrolone 4000 Norethandrolone 4000 Opiumcombination product 25 mg/du 9809 Oxandrolone 4000 Oxymesterone 4000Oxymetholone 4000 Pentobarbital & noncontrolled active ingred. 2271Pentobarbital suppository dosage form 2271 Phendimetrazine 1615Secobarbital & noncontrolled active ingred 2316 Secobarbital suppositorydosage form 2316 Stanolone 4000 Stanozolol 4000 Stimulant compoundspreviously excepted 1405 Sulfondiethylmethane 2600 Sulfonethylmethane2605 Sulfonmethane 2610 Talbutal 2100 Testolactone 4000 Testosterone4000 Thiamylal 2100 Thiopental 2100 Tiletamine & Zolazepam CombinationProduct 7295 Trenbolone 4000 Vinbarbital 2100

SCHEDULE IV DEA Substance Number Alprazolam 2882 Barbital 2145Bromazepam 2748 Butorphanol 9720 Camazepam 2749 Cathine 1230 Chloralbetaine 2460 Chloral hydrate 2465 Chlordiazepoxide 2744 Clobazam 2751Clonazepam 2737 Clorazepate 2768 Clotiazepam 2752 Cloxazolam 2753Delorazepam 2754 Dexfenfluramine 1670 Dextropropoxyphene dosage forms9278 Diazepam 2765 Dichloralphenazone 2467 Diethylpropion 1610 Difenoxin1 mg/25 ug AtSO4/du 9167 Estazolam 2756 Ethchlorvynol 2540 Ethinamate2545 Ethyl loflazepate 2758 Fencamfamin 1760 Fenfluramine 1670Fenproporex 1575 Fludiazepam 2759 Flunitrazepam 2763 Flurazepam 2767Halazepam 2762 Haloxazolam 2771 Ketazolam 2772 Loprazolam 2773 Lorazepam2885 Lormetazepam 2774 Mazindol 1605 Mebutamate 2800 Medazepam 2836Mefenorex 1580 Meprobamate 2820 Methohexital 2264 Methylphenobarbital(mephobarbital) 2250 Midazolam 2884 Modafinil 1680 Nimetazepam 2837Nitrazepam 2834 Nordiazepam 2838 Oxazepam 2835 Oxazolam 2839 Paraldehyde2585 Pemoline 1530 Pentazocine 9709 Petrichloral 2591 Phenobarbital 2285Phentermine 1640 Pinazepam 2883 Pipradrol 1750 Prazepam 2764 Quazepam2881 Sibutramine 1675 SPA 1635 Temazepam 2925 Tetrazepam 2886 Triazolam2887 Zaleplon 2781 Zolpidem 2783

SCHEDULE V DEA Substance Number Codeine preparations - 200 mg/100 ml or100 gm Difenoxin preparations - 0.5 mg/25 ug AtSO4/du Dihydrocodeinepreparations 10 mg/100 ml or 100 gm Diphenoxylate preparations 2.5 mg/25ug AtSO4 Ethylmorphine preparations 100 mg/100 ml or 100 gm Opiumpreparations - 100 mg/100 ml or gm Pyrovalerone 1485

Apart from the above-noted intranasal applicators, each loaded with aunit dose of intranasal ketamine, intranasal morphine, or mixturesthereof, other preferred drug delivery units include unit doses ofprescription drugs such as digoxin, β-blockers, α₂-antagonists, thyroidreplacement drugs, drugs to treat specific diseases (Alzheimer's, AIDS,diabetes, etc.), anticoagulants, vitamins having potentially toxicoverdosages, and any other ingestible, inhalable, injectable or topicaldrug that is provided according to a scheduled regimen. Otherrepresentative drugs include, but are not limited to: betamethasone,budesonide, cortisone, dexamethasone, hydrocortisone,methyl-predinisolone, prednisolone, triamcinolone, capecitabine,chlorambucil, cyclophosphamide, etoposide, hydroxyurea, imatinib,mercaptopurine, methotrexate, buprenorphine, butorphanol, codeine,hydrocodone, hydromorphone, levorphanol, meperidine, methadone,morphine, opium, oxycodone, pentazocine, oxymorphone, anisindione,dicumarol, warfarin, isocarboxazid, phenelzine, tranylcypromine,amitriptyline, amoxaphine, clomipramine, desipramine, doxapin,imipramine, nortriptyline, protriptyline, trimipramine, olanzapine,risperidone, quetiapine, ziprasidone, aripiprazole, clozapine,chlorpromazine, fluphenazine, trifluoperazine, perphenazine,thioridazine, haloperidol, thiothixene, molindone, loxapine,apomorphine, benztropine mesylate, entacapone,levodopa/carbidopa/entacapone, carbidopa/levodopa, pergolide, ropiniroleHcl, amantadine Hcl, and selegiline Hcl.

Broadly, in one embodiment, the device is intended to be loaded withmultiple doses of one or more drug delivery units and programmed toallow the drug delivery units to be dispensed at predetermined timeintervals. In another embodiment, the device is intended to be loadedwith multiple doses of one or more drug delivery units and programmed toallow the drug delivery units to be dispensed to a patient when desired,provided that a minimum time interval has passed between dispensingcycles. In another embodiment, patients requiring a regimen of severaldifferent drugs over an extended time period may use the device todispense the particular prescribed multi-drug regimen at specified timeperiods.

One necessary element of the present invention is a controllable timingmechanism which is in operable communication with a delivery systemwithin the device. While the timing mechanism will be discussed ingreater detail below, it is noted that it may be either an electrical ormechanical timing mechanism. Although both offer desired utility,mechanical timing mechanisms offer the advantage of employing the devicein the absence of an electrical source.

For dispensing of drug delivery units over a scheduled time period, itis contemplated herein that the timing mechanism may be controlledeither by the device manufacturer or at the time it is loaded with thedesired drug delivery units. Thus, in one non-limiting example, in whichthe devise is intended to dispense drug delivery units hourly over a 12hour time period, the timing mechanism may be preprogrammed by themanufacturer. In a further embodiment, the timing mechanism may includea user interface through which a particular dosing and time period maybe input. One such non-limiting example would allow a healthcarepractitioner to load the device with, for example, 12 doses ofintranasal ketamine, and then program the timing mechanism to allow thedevise to provide one dose every 2 hours.

Likewise, it is also contemplated that the device may include aninterface through which a patient may self-administer drugs on aninterval-limited basis. In this embodiment, the device may include apatient dosing interface through which the patient requests a drugdelivery unit to be dispensed. The timing mechanism may be programmed byeither the manufacturer or a healthcare practitioner to allow drugdelivery units to be dispensed freely, provided a minimum interval haspassed between each dispensing.

In one embodiment, the device may be used to simplify a complicateddosing regimen required by a patient. For example, many patients,particularly elderly patients, require doses of several different drugsone or more times per day. Selecting the particular drugs required atparticular times can often be complicated or confusing. In oneembodiment, the present invention provides a means by which properdosing may be simplified. In particular, the device may be loaded in amanner which allows several drug delivery units to be dispensed at onetime. As one example, consider the case of a patient requiring drugs A,B, and C every morning, and drugs B and D every evening. The chambers inthe magazine of the device may be loaded with alternating combinationsof drugs A, B and C and drugs B and D, and the device may be set todispense the alternating combinations to the patient at twelve hourintervals.

In a preferred embodiment, it is contemplated that the entire device,loaded with the required drug delivery units, may be provided to apatient. This configuration is best applied in situations where thedevice will be used for short periods, such as for acute post-surgicalpain relief. Upon termination of pain medication, the device may becleaned, loaded with drug delivery units for a different patient, sealedand re-used. Alternatively, in applications in which the device will beused for longer periods, a patient may be provided with a version of thedevice in which the magazine used to contain drug delivery units isabsent. In this case, a healthcare practitioner, pharmacist, or otherauthorized person may provide a magazine loaded with the appropriatedrug delivery units to the patient. Depleted magazines may be eitherrefilled, or replaced with fully loaded units.

The device may be best understood from the description below withreference to the accompanying Figures.

In one embodiment, shown in FIG. 1, the device 10 comprises a base 12, ahousing 14 having an aperture 16 which provides access to the interiorof the housing, a magazine 18 for containing drug delivery units and atleast one tamper indicia 20. Each of these elements, as well as otherdevice components (not shown in FIG. 1) is described in detail below.The device is well-suited for use with individual (FIG. 2 a) andmultiple (FIG. 2 b) intranasal drug delivery units, however, it is notintended to be limited in this manner. Rather, it is contemplated thatany of a wide variety of delivery units, including but not limited to,intranasal applicators, pills, capsules, caplets, syringes, inhalers,patches, vials, and the like may be used in connection with the device.

The base 12 of the device is depicted schematically as a top view inFIG. 3 a and side view in FIG. 3 b. In FIGS. 3 a and 3 b, the base 12comprises a substantially circular platform 22 containing a centralaperture 24. A wall 26 extends downward from the platform 22 peripheryto define an interior space below the platform. The interior spacecommunicates with the central aperture 24. Optionally, a plurality offeet 28 may extend from portions of the wall 26 to support the device.In some embodiments, it is desirable to provide the device 10 withtamper indicia 20 which provide evidence of attempts to open the deviceby unauthorized individuals. While such tamper indicia 20 will bedescribed in greater detail below, in one embodiment, the base 12 mayinclude one or more flanges 30 extending outwardly from the platform.These flanges may contain a bore 32 adapted to mate with similarstructures on the housing 14 to provide a means for securing the housing14 to the base 12 in a manner which would evidence attempts to separatethese elements and gain unauthorized access to the device interior.

The housing 14 of the device is depicted schematically as a top view inFIG. 4 a and side view in FIG. 4 b. In FIGS. 4 a and 4 b, the housingcomprises a substantially circular enclosure having a top 34 and a wall36 extending therefrom. As with the base 12, the housing 14 may includeone or more flanges 38 extending outwardly from the housing. Theseflanges may contain a bore 40 adapted to mate with similar structures onthe base 12 to provide a means for securing the housing 14 to the base12 in a manner which would evidence attempts to separate these elementsand gain unauthorized access to the device interior. The wall 36includes an aperture 42 allowing access to the interior of the housing.The aperture 42 may comprise simply a region on the circumference of thetop 34 from which the wall 36 does not extend, or it may be formed as aseparate opening in the wall. An optional door, not shown, may cover theaperture to prevent dust and other unwanted substances from entering thedevice interior. The door may include a simple mechanism that allows itto be opened when a drug delivery unit is available, and closes andoptionally locks it when a drug delivery unit is not available. Theaperture 42, with or without the optional door, must be large enough toallow a drug delivery unit to be removed from the device when it ispositioned within the housing 14 adjacent to the aperture 42.

Positioned within the device in the chamber formed between the base 12and the housing 14 is a magazine 50, shown in FIGS. 5 a-5 d. Themagazine 50 comprises a hub 52 having a link interface 54 and aplurality of partitions 56 extending therefrom. When positioned withinthe device in the chamber formed between the base 12 and the housing 14,the link interface 54 mates with a link (described below) and a timingmechanism (described below) to allow the magazine 50 to be rotatedwithin the device. The partitions 56 define storage regions for the drugdelivery units and serve to move the units through the device, towardthe aperture 42, as the magazine 50 is rotated in a controlled manner.The hub 52 may contain a drug delivery unit aperture 58 in the regionsformed between the partitions to assist in positioning each drugdelivery unit within the device. The number of partitions used dependson the particular anticipated dosing regimen with which the device willbe used, as well as the particular timing mechanism selected. Forexample, if the device is intended to dispense 12 drug delivery unitsover a 24 hour period, the device could have 12 partitions and a 24-hourtiming mechanism. As will be apparent from FIGS. 5 a and 5 b, a magazinehaving 12 partitions defines 12 storage regions between them. Likewise,in another non-limiting embodiment, shown in FIGS. 5 c and 5 d, themagazine may include 24 partitions to define 24 storage regions. Such adevice could be used to deliver 24 drug delivery units hourly over thecourse of a day when used with a one-day timing mechanism, or 12 drugdelivery units daily over the course of two days when used with atwo-day timing mechanism. Numerous other combinations of timing anddosing regimens will be apparent to those of ordinary skill in the art.

The magazine 50 is rotated within the device using a link 60 shown inFIGS. 6 a and 6 b. The link 60 comprises, generally, an axle having amagazine interface 62 and a timing mechanism interface 64. The magazineinterface 62 mates with the link interface 54 on the magazine 50 toallow the link, when rotated, to rotate the magazine. The timingmechanism interface mates with a timing mechanism, described below,which rotates the link and the magazine in a controlled manner.

The timing mechanism 70 is depicted schematically in FIG. 7. It isanticipated that any of a wide variety of timing mechanisms may beembodied in the present invention. For example, the timing mechanism maybe an electrical timer that is driven by AC current, or it may be anelectrical timer that is driven by battery power. In one preferredembodiment, however, the timing mechanism is a mechanical timer.Mechanical timers are preferred because they are simple, durable,reliable and do hot require a current source to operate. Thus, the useof a mechanical timer allows the device to be employed in a wide varietyof environments where electrical timers would offer little or nousefulness. For example, the device of the present invention is wellsuited for military applications where AC current may be unavailable.Likewise, the device is suitable for civil defense applications where itmay be stored for extended periods of time prior to use. Mechanicaltimers are unaffected by such storage, whereas batteries may not bereliable in such circumstances.

The timing mechanism 70 is selected such that it provides the magazinewith one complete rotation over a predetermined dosing period. Thus, a“one-day” timing mechanism is one that provides the magazine with onecomplete rotation over a 24 hour period, a “two-day” timing mechanism isone that provides the magazine with one complete rotation over a 48 hourperiod, a “half-day” timing mechanism is one that provides the magazinewith one complete rotation over a 12 hour period, etc. The timing deviceincludes a rotating rod that mates with the link via the timingmechanism interface 64. As such, as the rod on the timing mechanism isrotated, it rotates the link, which, in turn, rotates the magazine.

The timing mechanism 70 may optionally include an audible and/or visualindicator that provides an indication when a drug deliver unit isavailable for withdrawal from the device. The audible indicia may be,for example, a bell that rings when a dose is available, and the visualindicia may be, for example, a colored segment that becomes visiblethrough the aperture 42 when a dose is available. Thus, in the case of a12 dose regimen over the course of one day, an audible indicia wouldsound every two hours.

As noted in FIGS. 3 a and 3 b and FIGS. 4 a and 4 b, the device mayinclude tamper indicia. In the embodiments shown, the tamper indicia 20comprises flanges on the base and the housing each having a bore throughwhich a seal may be inserted. In one preferred embodiment, the sealcomprises an electrical tie-wrap which can be formed into a loop using aone-way ratchet mechanism thereon. By inserting tie wraps through theflanges on the base and housing, the base and housing are securedtogether in a manner that prevents unauthorized access to the interiorof the device unless the tie wraps are cut.

The device is not intended to be tamper-proof. Rather, the device isintended to provide an indication to a healthcare practitioner thatunauthorized access, or attempts at unauthorized access, to the deviceinterior have occurred. It should be understood as well, that any of awide variety of devices may be used to secure the housing to the basevia the flanges. These include dial locks, keyed locks, scored labelsand tapes, etc.

In one embodiment of the assembled device, a mechanical timing mechanismis mounted to the underside of the base in a manner such that rotatingrod extends through the center of the base and mates with the timingmechanism interface on the link. The magazine, selected for theparticular dosing regimen and loaded with drug delivery units ispositioned on the base in a manner such that it mates with the magazineinterface on the link. The housing is positioned over this assembly andthe tamper indicia is employed to hold the housing to the base. In onepreferred embodiment, the drug delivery units comprise intranasaldispensers of analgesic medications intended to be dispensed every twohours over the course of a full day. As such, a one-day timer and amagazine having 12 partitions is employed.

The device above could be stored until needed, and then employed simplyby providing it to a patient and activating the mechanical timingmechanism, such as by winding. The timing mechanism will begin to rotatethe magazine within the device in a manner such that a patient canwithdraw one drug delivery unit from the aperture in the housing everytwo hours. Once a drug delivery unit is removed from the device, anotherone will not be available until the magazine has rotated sufficiently tomake another drug delivery unit available. If the patient attempts toaccelerate the dosing by gaining access to the interior of the device,this attempt will be evident via the tamper indicia. If the dosing isintended to be continued over the course of a second day, a healthcarepractitioner can open the device, and either reload the magazine orreplace it with a preloaded magazine.

In other embodiments of the present invention, individuals may use thedevice at home to dispense medications according to their particularneeds. Thus, a patient taking multiple medications over the course ofone or more days may load the magazine, or obtain personalized preloadedmagazines, to provide the appropriate medications at the appropriatetimes.

The individual elements of the device may be made of any of a widevariety of materials. In one preferred embodiment, the base, housing,link and magazine are fabricated from a cast or thermoformed polymer. Itis anticipated that the device may be employed in a manner where theelements are reusable, and thus, durable plastics are preferred. In oneembodiment, however, the base, housing, timing mechanism and link areintended to be made available as a packaged unit, and the magazine,loaded with the appropriate drug delivery units is obtained separately.In this case, the magazine may be returned during the process ofrefilling, or it may be discarded. In the latter case, it is preferredthat the magazine be formed of a biodegradable or recyclable material.

The device of the present invention offers a simple, durable alternativeto conventional patient controlled analgesia (PCA) devices. Unlikecommon PCA systems, a preferred embodiment the present invention canoperate in the absence of electrical power, while providing periodicdoses of analgesics in a manner that is tamper evident andself-accounting.

The device lends itself to use in hospitals, semi-supervised careenvironments, and independent supervised care environments. In postoperative patients, the device reduces the cost of care as there is noneed for a healthcare practitioner to periodically administer thedispensed medications. For end-of-life care, the device can be used todeliver analgesic medications at a greatly reduced cost and improvedsafety. For settings where the patient needs assistance with determiningwhen to take the medications, i.e., nursing homes, the device reducesthe needs for a healthcare practitioner at each dosing event. Finally,in natural disaster or military situations, the device provides adurable means of dispensing medications in environments where electricalpower may be unavailable.

Equivalents

The present invention is not intended to be limited in scope by thespecific embodiments described herein, each of which is presented by wayof example only. Various modifications of the invention in addition tothose described herein will become apparent to those skilled in the artfrom the foregoing description and the accompanying figures. Suchmodifications are intended to fall within the scope of the claims.

1. A device for the controlled release of drug delivery units, whichcomprises: a) a magazine for containing a plurality of drug deliveryunits; b) a housing containing the magazine, said housing having anaperture allowing drug delivery units to be removed therethrough; c) alink by which the magazine may be moved relative to the housing; and d)a mechanical timing mechanism in communication with the link, forcausing the magazine to be moved relative to the housing, therebyperiodically allowing removal of individual drug delivery units throughthe aperture.
 2. The device of claim 1, wherein the magazine isconfigured to hold 12 drug delivery units.
 3. The device of claim 1,wherein the magazine is configured to hold 24 drug delivery units. 4.The device of claim 1, further including at least one tamper detectionelement.
 5. The device of claim 4, wherein the tamper detection elementprovides an indication of at least one condition selected from the groupcomprising: opening the housing, adjusting the timing mechanism,movement of the magazine by other than the timing mechanism, andattempts of each.
 6. The device of claim 1, wherein the magazine movesrelative to the housing via rotation.
 7. The device of claim 6, whereinthe link comprises an axle upon which the magazine may be rotated. 8.The device of claim 7, wherein the timing mechanism communicates withthe axle in a manner such that drug delivery units may be removed atpre-selected time intervals.
 9. The device of claim 1, wherein thecombined plurality of drug delivery units in the magazine comprises adaily drug dose for a patient.
 10. The device of claim 1, wherein eachof the drug delivery units comprises a single unit dispenser fordelivering a drug selected from the group comprising intranasalketamine, intranasal morphine, and mixtures thereof.
 11. The device ofclaim 10, wherein each of the drug delivery units comprises a Pfiefferintranasal applicator.
 12. The device of claim 1, wherein the apertureis accessed via a door.
 13. The device of claim 1, further including apatient dosing interface.
 14. The device of claim 13, wherein thepatient dosing interface includes a lock-out to prevent removal of drugdelivery units at time intervals less than a pre-selected minimuminterval.
 15. The device of claim 1, further including an indicator toalert a patient that a drug delivery unit is available.
 16. The deviceof claim 15, wherein the indicator is an audible alarm, a visualindication, or a combination of both.
 17. The device of claim 1 whereinthe drug delivery units are intranasal, ingestible, topical orinjectable drug delivery units.
 18. A device for the controlled releaseof drug delivery units, which comprises: a) a magazine for containing aplurality of drug delivery units; b) a housing containing the magazine,said housing having an aperture allowing drug delivery units to beremoved therethrough; c) a link by which the magazine may be movedrelative to the housing; and d) a mechanical timing mechanism incommunication with the link, for causing the magazine to be movedrelative to the housing, the device having a time-based lock-out toprevent access to the magazine except at pre-selected time intervals,thereby allowing removal of individual drug delivery units through theaperture only at pre-selected time intervals. 19-34. (canceled)
 35. Asystem for the controlled delivery of drugs, the system comprising: a)at least one drug delivery unit; b) a magazine constructed and arrangedto contain a plurality of drug delivery units, the magazine containingsaid at least one drug delivery unit; c) a housing containing themagazine, said housing having an aperture allowing said at least onedrug delivery unit to be removed therethrough; d) a link by which themagazine may be moved relative to the housing; and e) a mechanicaltiming mechanism in communication with the link, for causing themagazine to be moved relative to the housing, thereby periodicallyallowing removal of individual drug delivery units through the aperture.36-51. (canceled)
 52. A method for providing drug delivery units to apatient at pre-selected time intervals, the method comprising the stepsof: a) providing a system for the controlled delivery of drugs, thesystem comprising: i) at least one drug delivery unit; ii) a magazineconstructed and arranged to contain a plurality of drug delivery units,the magazine containing said at least one drug delivery unit; iii) ahousing containing the magazine, said housing having an apertureallowing said at least one drug delivery unit to be removedtherethrough; iv) a link by which the magazine may be moved relative tothe housing; and v) a mechanical timing mechanism in communication withthe link, for causing the magazine to be moved relative to the housing,thereby periodically allowing removal of individual drug delivery unitsthrough the aperture; b) providing the timing mechanism with dataindicative of the dosing schedule for the patient; c) activating thetiming mechanism to thereby allow the patient to withdraw drug deliveryunits from the system according to the dosing schedule. 53-68.(canceled)
 69. A device for the controlled release of drug deliveryunits, which comprises: a magazine containing a plurality of drugdelivery units, wherein the magazine is intended to operate with adevice comprising: a) a housing for containing the magazine, saidhousing having an aperture allowing drug delivery units to be removedtherethrough; b) a link by which the magazine may be moved relative tothe housing; and c) a mechanical timing mechanism in communication withthe link, for causing the magazine to be moved relative to the housing,thereby periodically allowing removal of individual drug delivery unitsthrough the aperture. 70-78. (canceled)